Safety Study of SLC-391 in Subjects With Solid Tumors
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase
AXL with desirable potency and pharmaceutical properties. It has demonstrated
antiproliferative activity against different tumour cell lines in vitro and efficacy in
different animal models including nonsmall cell lung cancer (NSCLC), chronic myeloid leukemia
(CML) and (acute myeloid leukemia (AML) models. It has also exhibited strong synergy with
other approved targeted therapies in different animal models.
This is the first clinical study with SLC-391. The goals of this study are to evaluate the
safety, pharmacokinetic (PK), and pharmacodynamic profile of SLC-391, and then to identify a
safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical
studies. In addition, change from baseline of possible blood biomarkers (soluble AXL and Gas
6) may be evaluated.
This is an open-label, multicentre, phase 1, dose-escalation, first in human study to
evaluate the safety of SLC-391 administered orally (once or twice daily) in 21-day cycles to
subjects with advanced solid tumours.